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Rotavirus (ROV) Antigen Detection Kit



[Product name]

Rotavirus Antigen Detection Kit (Colloidal Gold)

[Packing specification]

Sealed package with foil bags, every bag contains the dosage taken once for each person.

[Intended application]

Acute diarrhea disease in young children is a major cause of morbidity worldwide and is a leading cause of mortality in developing countries. Rotavirus is the most common agent responsible for acute gastroenteritis, mainly in young children. Rotavirus is transmitted by oral-fecal route with an incubation period of 1-3 days. In temperate climates, rotavirus infections occur mainly in the winter months. The Rotavirus Test Device is a rapid chromatographic immunoassay for the qualitative detection of rotavirus in human fecal specimens to aid in the diagnosis of rotavirus infection.

[Inspection principles]

Rotavirus antigen Rapid Test is a immunoassay utilizing highly specific reactions between double antibodies sandwich for the detection of rotavirus antigen in human stool samples.

The function parts of the test kit are diluting liquid and test cards which contain immunological reagent on the chromatographic membrane. The stationary reagent line that has been applied onto the membrane in the test area (T) is otherwise invisible, but if the sample passes through membrane contains rotavirus antigen to the specific rotavirus antibody, the line turns distinctly red in the test area. The control line that has been put on the membrane in the control area (C) invisible before the test turns red during the assay process, thus indicates proper performance of the test device. Regardless of the existence of Rotavirus antigen in the sample, the control line will appear.



[Main components]

[Storage conditions and period of validity]

Avoid light, dry preservation at 2-30℃,no cryopreserving. The period of validity is 24 months since the date of production


[Test method and limitations]

1. The kit is only used for detecting Rotavirus antigen in the samples of human stool.

2. Accuracy of the detection depends on the sampling progress, if the sampling and storage are improper, or the sample is not fresh, or the sample is conducted freeze and thaw, all above can affect the detection results.

3. If the sample is stored in individual medicines, such as OTC with high concentration and prescription medicines, the detection results may be interfered. If the results are suspicious, please test again.

4. The test card can only be used for qualitative detection of Rotavirus antigen in the human stool samples. If you want to detect specific contents of some indicator, please use relevant special instruments.

5. The positive results only show the existence of Rotavirus antigen in the samples, and which can not be treated the only standard to judge that the organism has infected Rotavirus antigen. And the detection results must be diagnosed by the doctor combining with other clinical symptoms as well as the detection indicators from other laboratories.

6. If the detection results negative, but there are clinical symptoms, we suggest using other clinical methods for testing. The negative results can not completely eliminate the possibility of infecting rotavirus antigen.

[Performance indexes of the products]

1) Detection Limit

Minimal detection limit for Rotavirus antibody is 1/1000.

2) Interfering substances

When the sample concentration is below the level of the material shown in the following list, and does not affect the test results.

3) Cross Reaction

When the sample concentration is below the level of the 107 bacteria/ml , and does not affect the test results.

The results show that those bacterias in stool specimens above are all negative.



[Descriptions and notes]

1. The test strip /test card can only be used for in vitro diagnosis test. And which is suitable for testing the samples of human stool samples, and you may not get accurate results about other body fluid and samples.

2. In the test environment, there shall be not wind, no high temperature and high humidity; the test environment shall be not too dry.

3. When the package is opened, the test stripe/card shall be tested as soon as possible, to avoid being stayed in the air for a long time, resulting in damp and invalid. If the inner package is damaged, the product shall be not used.

4. The kit can be stored at room temperature, avoid damp. The kit stored at low temperature can not be used until it is balanced to room temperature.

5. Operate according to inspection rules of the infectious disease laboratories.

6. If the detection results take on negative, while there are clinical symptoms, we shall conduct further clinical detection. The negative results can not eliminate the possibility of Rotavirus antigen.

7. We can only get initial screening products using this method; any positive results shall be further confirmed adopting other methods.

8. When testing a large number of samples, pleas make tags, avoid confusion.

9. The test card can only be used for disposable in vitro diagnosis; and the same test card can not be used repeatedly. After being frozen or invalid, the test cart must not be used.

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.